Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours Infusion of Ularitide.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-11-30

Brief Summary

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This clinical trial intends to investigate the safety, tolerability and efficacy of ularitide on the renal response in patients with liver cirrhosis and refractory ascites for a maximum exposure duration of 48 hours, through a randomized, placebo-controlled, double-blind, single-center trial.

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Detailed Description

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The investigators hypothesize that ularitide infusion is more effective than placebo to induce and maintain clinically meaningful natriuresis and diuresis in patients with liver cirrhosis and refractory ascites.

Participants will be given ularitide or placebo intravenously while hospitalized at Department of Hepatology and Gastroenterology at Aarhus University Hospital. During the hospitalization blood and urine samples are frequently collected.

30 ng/kg/min is the starting dosage for all participants. Depending on effects and/or side effects, ULA04 is designed to individualize treatment doses by up- and/or downtitration of the infusion dose within a predefined dose range. Relevant safety precautions are incorporated in the study design and treatment will be prematurely discontinued if a pre-defined stopping criteria presents.

Patients will be followed up for the appearance of serious adverse events 30 days after the treatment.

If a separate written consent is given by the participants, additional blood and urine samples will be collected and stored in a biobank for future research.

Conditions

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Cirrhosis, Liver Ascites Hepatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ularitide

Test product. Continuous intravenous infusion with 30 ng/kg/min for 48 hours.

Group Type EXPERIMENTAL

Ularitide

Intervention Type DRUG

Continuous intravenous infusion for 48 hours at a dose of 30 ng/kg/min. Depending on effect and/or side effects dose can be adjusted to 15 ng/kg/min or 45 ng/kg/min.

Placebo

Matching placebo. Continuous IV infusion for 48 hours.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Continuous intravenous infusion for 48 hours at a bodyweight-adjusted infusion rate.

Interventions

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Ularitide

Continuous intravenous infusion for 48 hours at a dose of 30 ng/kg/min. Depending on effect and/or side effects dose can be adjusted to 15 ng/kg/min or 45 ng/kg/min.

Intervention Type DRUG

Placebo

Continuous intravenous infusion for 48 hours at a bodyweight-adjusted infusion rate.

Intervention Type DRUG

Other Intervention Names

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Urodilatin

Eligibility Criteria

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Inclusion Criteria

* Men and women \>18 years
* Liver cirrhosis confirmed by fibroscan (\>20 kPa), or by imaging with signs of an irregular liver surface with collaterals, or clinically by cirrhosis stigmata
* Refractory ascites Definition: failure to respond to or intolerance to high dose diuretics (spironolactone up to 400mg/day and furosemide up to 160mg/day) and early ascites recurrence (reappearance of grade 2 or 3 ascites within 4 weeks of initial mobilization or ≥2 paracentesis within last 3 months)
* Urine sodium excretion \<60 mmol/24 hour
* Serum creatinine \<150 µmol/L
* Child-Turcotte-Pugh score of B or C (\<13)
* Bilirubin \<150 µmol/L
* Prothrombin time (PP) 0.20-0.60 (INR 1.3-2.5)
* Systolic blood pressure ≥95 mmHg
* Written informed consent to participate in the clinical trial

Exclusion Criteria

* Gastrointestinal bleeding within 2 weeks prior to inclusion
* Proteinuria \>500 mg/day
* Hemoglobin \<5.5 mmol/L
* Spontaneous bacterial peritonitis within 2 weeks prior to inclusion
* Loculated ascites
* Hepatic encephalopathy grade 2-4 (West-Haven classification)
* Obstructive uropathy
* Primary kidney disease
* Known diagnosis of congestive heart failure
* Known diagnosis of acute-on-chronic liver failure
* Known diagnosis of systemic inflammatory response syndrome
* Acute infections by known diagnosis and/or antibiotic treatment
* Known HIV infection
* Known allergy to the investigational drug or other natriuretic peptides
* Treatment with dobutamine, levosimendan, milrinone, any phosphodiesterase inhibitor, octreotide, midodrine, vasopressin, dopamine or other vasopressors within 2 weeks prior to inclusion
* Nephrotoxic drugs within 1 month prior to inclusion
* Fertile women not using contraception, either an intrauterine device or hormonal contraception
* Positive pregnancy test in pre-menopausal women or in breast-feeding women
* Participation in an interventional clinical drug trial within 1 month prior to inclusion
* Legal incapacity or limited legal capacity
* Patients who are employees or relatives of the investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No